ORTHOMET PERFECTA TOTAL HIP SYSTEM

ORTHOMET PERFECTA TOTAL HIP SYSTEM is an FDA 510(k)-cleared medical device (K923583) manufactured by Orthomet, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 1992. Regulation: 8.